Leading The Way in Phytomedicines - Company Presentation - MGC Pharma
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Leading The Way in Phytomedicines Company Presentation
Corporate Overview
MGC Pharmaceuticals Ltd (ASX/LSE: MXC) is a European Shareholder Breakdown
based bio-pharma company developing and supplying
affordable standardised phytocannabinoid derived 9% 4%
medicines to patients globally, for the immediate growing Directors/Management
demand in the existing medical markets in Europe, North
America and Australasia and future key markets. Independent shareholders
25%
MGC Pharma has a growing patient base in Australia, the UK,
Brazil and Ireland and has a global distribution footprint via UK Institutional Funds and
an extensive network of commercial partners meaning that Family Offices
62%
it is poised to supply the global market. UK Retail investors
Issued Capital Capital Structure
Ordinary shares 2,279,465,616 ASX/LSE Code MXC
Listed Options ($0.045, expiring 31 August 2021) 80,777,228 Market Capitalisation (as at 08 April 2021) ~$160m
Performance Rights 10,000,000 Share price (as at 08 April 2021) $0.070
Unlisted Options & Convertible Notes ($0.05 - $0.15) 62,500,000 Cash at Bank (as at 31 March 2021) ~$10m
Convertible Notes 3,850,000
MGC Pharma | Company Presentation | April 2021 2
Company Mission
“To Build an Innovative, Vertically Integrated bio-pharma company providing Standardised, Affordable
PhytoMedicines of the Highest Regulatory Compliance for Targeted global markets and patients”
Financial Year Cumulative Phytocannabinoid Product Growth*
$1,400,000 9,000
8,000
$1,200,000
7,000
$1,000,000
6,000
$800,000 5,000
$600,000 4,000
3,000
$400,000
2,000
$200,000
1,000
$- 0
Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21
Cumulative sales Monthly sales Cumulative units
* Excludes sales of ArtemiC
MGC Pharma | Company Presentation | April 2021 3
Board of Directors
Highly qualified team, each with over 15 years of relevant industry experience
Roby Zomer Brett Mitchell Nativ Segev Dr. Stephen Parker Dr. Ross Walker Evan Hayes
Managing Director, CEO & Executive Chairman & Non- Executive Director & Senior Independent Director & Independent Director & Independent Director
Co. Founder Co. Founder Co. Founder Chairman of Audit and Board Head of Medical Advisory
Committees Board
Following 10 years of experience in With over 20 years of experience The founder of MGC Pharma, Dr. Parker has over 30 years of Dr. Walker is a well-known figure Evan Hayes is a highly experienced
the BioTech and AgroTech sectors in the founding, financing and previously CEO of an Israeli corporate finance, directorship, in Australian health, as former Board member and brings over
alongside running large scale management of both private and licensed Medical Cannabis corporate advisory and investment host of a weekly radio programme 20+ commercial and leadership
projects, Mr. Zomer joined MGC publicly listed companies, Mr. company, with over 10 years of banking experience focused on and a prominent cardiologist who experience within the healthcare
Pharmaceuticals as Executive Mitchell is responsible for the experience in the global medical the pharmaceutical and specialises in echocardiography and biotechnology sectors. Mr
Director & CTO, bringing his corporate strategy, capital cannabis industry and over 15 biotechnology sectors in the UK, and preventative cardiology. Dr. Hayes graduated with a Master of
extensive business contacts, markets and financial years of experience in executive Europe and North America, such Walker has published several Science 1st Class Honours
scientific and engineering skillset to management of the company, and roles. Founded MGC Pharma to as the Chairman of Sareum books, and lectures both (Biotechnology) from the National
bear on ensuring MGC’s position as is integrally involved in assisting in expand into the International Holdings plc. Dr. Parker is nationally and internationally. His University of Ireland, Galway and
a leader in research and building a new industry from the markets and to raise the quality regarded as a leading corporate contacts in the medical prior to this he finished first in his
development, as well as ensuring ground up in Australia. and viability of medicinal expert and strategic thinker. He establishment and beyond allow class from the National University
top performance from our global phytocannabinoid products. has a reputation for rapid and him to facilitate relationships for of Ireland, Cork with a Bachelor of
operations. clear analysis and the ability to MGC and draw positive public Science degree (Honours). Mr
translate this analysis into an attention to the brand. Hayes’ has also won the Daniel
implemented solution. O'Carroll Award for Scientific
Research.
MGC Pharma | Company Presentation | April 2021 4
Key Clinical and Operational Management
Leading experts in the medical cannabis space with unparalleled expertise
Sasha Friedman Nicole Godresse Dr. Jonathan Grunfeld Prof. Uri Kramer Dr. Nadya Lisovoder Amir Polak
Chief Operations Officer Global Chief Sales Officer Chief Medical Officer Head of Neurology Head of Clinical Research Chief Technology Officer
Deputy CEO Head of Oncology Product Development (CRO) and Regulatory
Nicole has over 20 years’
12 years of experience in Business experience in the Certified in Israel, with clinical Prof Kramer has a busy paediatric 15 years of domestic and Mr. Polak is a scientist who, for
Process Design and implantation pharmaceutical/healthcare experience at the MD Anderson epilepsy clinic with many patients international experience in the last 15 years, has been
as a Senior Consultant for Deloitte industry, holding senior roles with Cancer Center, Dr. Grunfeld has being treated with cannabis. Prof academic and clinical studies in working within the chemical
and a Project Manager in Tel-Aviv- major multi-national companies spent the last twenty years Kramer has run full scale epilepsy the pharmaceutical, diagnostic industry in various fields including
Jaffa municipality. Implementing including Eli Lilly, Johnson & focusing on Neuro-Oncology, with trials with cannabis and brings a and medical devices industry. Dr. pharmaceutical, fuel, bio-fuel and
business solutions in various Johnson, Schering-Plough, Merck a focus since 2010 on Cannabis as wealth of experience in various Lisovoder is a regulatory expert 3D printing, from inception
industries for Enterprise and SMB Sharp & Dohme and most recently a treatment for oncological fields (Paediatric Neurology & and has been a clinical adviser to through to release to market. Mr.
organizations globally and leading Tilray. In her most recent roles as palliative care. Involved in the Child Development). Additionally, public biotech companies as well Polak has an MSc in Chemistry
cross-sectional teams General Manager ANZ and Director licensing of care including direct Prof Kramer is a former president as incubator companies. She has from the Hebrew University
of Emerging Markets at Tilray, clinical monitoring of circa 5,000 of the Israeli League Against managed clinical trials and has (Jerusalem).
Nicole was Instrumental in medical cannabis patients in Israel, Epilepsy. been leading for the Israeli
launching the first Medical Cannabis giving him a unique insight into government biomedical research
brand legally in both Australia and questions of dosing, patient in 7 hospitals in northern Israel in
New Zealand, launching one of the groups and developing treatment cooperation with universities,
first Medical Cannabis clinics in methodology. international Pharma companies,
Australia, delivering some of global CROs and biotech
Australia's first government funded companies.
cannabis clinical trials and
negotiating major exclusive
government supply agreements.
MGC Pharma | Company Presentation | April 2021 5
Company Highlights
MGC Pharma is a European based, vertically integrated bio-pharma company supplying EU-GMP
Phytocannabinoid derived products to patients, with increasing product sales in Australia, NZ, UK, Ireland and
Brazil through special access schemes, and new key markets opening in EU and Israel
Since 2018 MGC has held GMP certification for the manufacture of
Investigational Medical Products at the Slovenian facility
Three Investigational Medicinal Products (IMPs) in three clinical trials (Phase II
and Phase III)
Additional targeted products in development pipeline with wide IP
developments and new Phytotherapeutics line
Rapid growing patient base – delivering affordable cannabinoid medicines to
patients. Record quarter of sales & revenue in December 2020 quarter
Global distribution via extensive network of commercial partners and direct
patient access in Australia via acquisition of Medicinal Cannabis Clinics
Highly qualified management team, supported by leading clinical advisory
experts
MGC Pharma | Company Presentation | April 2021 6
Company Strategy
Development and commercialisation of Phytocannabinoid derived products through a vertically integrated, core
IP value chain delivering a “Nature to Medicine” business strategy with global distribution capability in place
Extraction & Clinical Product
Genetics Distribution
Isolation into API Trials Development
High THC >35% strains Super Critical (Co2) Europe (EMA) Europe UK, EU, Australia, NZ
High CBD >20% Strains Alcohol Extraction Australia (TGA) Australia LATAM, MENA
MGC Pharma | Company Presentation | April 2021 7
Products
Research &
Development
MGC Pharma | Company Presentation | April 2021 8
Phytomedicines − Investigational Products
MGC’s Phytomedicines are Plant based products proceeding through clinical trails to obtain marketing
authorization, which will allow doctors around the world to prescribe a product with accurate claim to treat
symptoms
These investigational products allow MGC Pharma to provide prescription and OTC medicines at an affordable
price point, in comparison to the alternative treatments for untreated conditions
These products are the outcome of years of experience and development of our medical team, produced under
strict GMP guidelines with QA/QC/QP controls and audit
CannEpil® designed as a treatment for refractory epilepsy
CogniCann® designed to improve dementia and Alzheimer’s disease patients quality of life
CimetrATM as a treatment to offset the Cytokine Storm and other auto-immune indications
Clinical trials and educational symposiums along side training and patient support platform increasing the access
of medicines to the market
MGC Pharma | Company Presentation | April 2021 9
Clinical R&D – Key Products Trials
Three research areas based on medical experience and large data collections. MGC Pharma has commenced the
following clinical trials for three of its key Phytomedicine products CannEpil®, CogniCann® and CimetrA™
Research Areas Key Products
Neurology Phase IIb Clinical Trial at Schindler Hospital in Israel on the safety and efficacy of CannEpil®
CannEpil® as an add on treatment in children and adolescents with refractory epilepsy
• Epilepsy
• Dementia Phase II Clinical Trial with the University of Notre Dame in Perth, WA to evaluate the potential
• Cerebral Palsy CogniCann® behavioural benefits CogniCann® may have on patients with dementia and Alzheimer’s disease
Autoimmune CimetrA™ does not contain cannabinoids, designed from 4 natural ingredients as a phyto
CimetrATM medicine to target viral infections with inflammatory complications. In December 2020 has
• Anti-Inflammatory completed its Phase II Clinical Trail at Nazareth Hospital EMMS, Hillel Yaffe Hospital in Israel
• Anti-Bacterial and Mahatma Gandhi Mission’s Medical College & Hospital in India
Results from the trial successfully show CimetrA™ met all its primary and secondary endpoints
and statistically significantly improved the clinical recovery of COVID-19 infected patients.
CimetrA™ has just been approved for Phase III Clinical Trial starting at Nazareth Hospital
MGC Pharma | Company Presentation | April 2021 10Neurological
CannEpil® Disorders
CannEpil® is a Phytocannabinoid derived IMP used as a treatment for refractory epilepsy
• Available to prescribe in Australia and UK as Epilepsy
an Investigational Medicinal Product
through early patient access schemes Target Market:
• CannEpil® is an oral oil solution of 20:1 • Over 1,900,000 people have epilepsy in Europe The global
cannabidiol (CBD) and (-)- trans-Δ9- (over 480,000 epilepsy patients in UK) epilepsy market
tetrahydrocannabinol (THC) is expected to be
• Produced from two proprietary, • Over 200,000 epilepsy patients in Australia ~A$12.9bn
preselected, specifically bred genotypes of • Approximately 25% of people with epilepsy have a by 2023
the cannabis plant with a stable and specific drug-resistant (DRA) form
ratio of cannabinoids
• Estimated population at launch of marketing
• MGC’s first pharmaceutical-grade product
targeted for drug resistant (refractory) authorisation is over 200,000 people with DRA
epilepsy, which accounts for approximately (in Europe and Australia)
25% of the people diagnosed with epilepsy • Expected time to marketing authorisation 4 years
• Estimated yearly average treatment costs per
patient: A$10,000 – A$14,000
As originally announced in November 2019, Company Presentation – UK and Australia Roadshow
Source of target market: Alacrita Market Projections Report; Source of estimated average treatment costs (within the EU): Alacrita Market Projections Report; Source of epilepsy medication market: Medgadget Market Research Future
MGC Pharma | Company Presentation | April 2021 11Neurological
CogniCann® Disorders
CogniCann® is MGC Pharma’s second Phytocannabinoid derived IMP designed to improve
dementia and Alzheimer’s disease patients quality of life
• Available to prescribe in Australia as an Dementia
Investigational Medicinal Product through
Early Patient Access Scheme Target Market:
The
• CogniCann® is a oromucosal spray of • Over 690,000 people with mild dementia in global dementia
cannabidiol (CBD) and (-)- trans-Δ9- Europe (over 200,000 mild dementia patients
tetrahydrocannabinol (THC) medication market
in UK) is expected to exceed
• Produced from two proprietary, preselected, • Over 135,000 mild dementia patients in Australia ~A$40bn
specifically bred genotypes of the cannabis by 2026
plant with a stable and specific ratio of • Total estimated with mild dementia population
cannabinoids 950,000 at marketing authorisation launch
• Contains a 3:2 mix of THC (25mg/mL) and (in Europe and Australia)
CBD (17mg/mL)
• Expected time to marketing authorisation 5 years
• Estimated yearly average treatment costs per
patient : A$7,800
As originally announced in November 2019, Company Presentation – UK and Australia Roadshow
Source of target market: Alacrita Market Projections Report; Source of estimated average treatment costs (within the EU): Alacrita Market Projections Report and Internal Company Evaluation; Source of dementia medication market: Coherent
Market Insights through GlobalNewswire
MGC Pharma | Company Presentation | April 2021 12Autoimmune
CimetrA™ Disorders
CimetrA™ is a phyto medicine based on natural ingredients from Artemisinin, Curcumin,
and Boswellia serrata, has clinically proven effective in arresting the cytokine storm in COVID-19 patients
• CimetrA™ uses an enhanced delivery system technology, a Target Market:
platform to deliver natural ingredients more effectively in
higher concentrations to the cells, improving bioavailability • The entire world is currently CimetrA™ has
of natural ingredients affected by COVID-19 and been approved for
seeking solutions Phase III
• The Phase II human clinical trial testing CimetrA™ for
treatment of COVID-19 included 50 patients across three • Success of the ArtemiC food Clinical trials
hospital sites, Nazareth Hospital EMMS, Hillel Yaffe Hospital supplement formulation starting April 2021
in Israel and Mahatma Gandhi Mission’s Medical College & suggests an immediate market
Hospital in India for Cimetra™
• 33 Patients were in the treatment group and 17 patients
• Expected time to fast tracked
were in the placebo group
marketing authorisation less
• CimetrA™ successfully met all its primary and secondary than one year
study endpoints (100% of patients in the treatment group),
and all FDA requirements for diversity of patients
• None of the patients in the treatment group required
additional oxygen, mechanical ventilation or admission to
intensive care
MGC Pharma | Company Presentation | April 2021 13R&D – Preclinical
Developing medicines that leverage its proprietary medical cannabis formula through clinical trials in Israel,
Europe and Australia. Enable future medical product sales across the EU, Australia and other geographies,
following the legal and regulatory approvals
Neurological
CepaCann Oral Spray to treat Cerebral Palsy Preclinical in process
Oncological & Cancer Side Effects
Tetrinol Treatment of Anorexia Cachexia in Cancer Patients Preclinical in process
MXOT01GB01 Treatment of Glioblastoma (NIB Slovenia) Preclinical in process, Phase I planned H2 2021
MXOT02ME01 Treatment of Melanoma Cancer (RMIT/CannaHub, Aus) Preclinical in process
MXOT03PC01 Treatment of Prostate Cancer (RMIT/CannaHub, Aus) Preclinical in process
Autoimmune Disease – Inflammatory
InCann BiActive Capsule to treat Chron’s and IBS (RMIT/CannaHub, Aus) Preclinical in process, Phase I planned H2 2021
TopiCann Topical treatment of Eczema and inflamed skin (Slovenia, EU) Study Results: 70% Reduction in 4 weeks
MGC Pharma | Company Presentation | April 2021 14Proprietary MGC Drug Delivery Technology
Smart nanostructured materials for drug delivery
Nano-emulsion, Nano particles & Core-shell microcapsules
MGC is currently conducting research development on smart
nanostructured materials to deliver drugs to the target sites with
reduced dosage frequency and in a controlled manner, to mitigate the
side effects experienced with traditional therapies.
In particular, to resolve the main critical
issues encountered with conventional
pharmaceutical treatments with the
following:
• Specific distribution of the API
• Controllable release of the API
• High bioavailability
MGC Pharma | Company Presentation | April 2021 15Strategic Partnership with RMIT
MGC Pharma and RMIT have developed the CannaHub, a digital research hub for the application of
Phytocannabinoid derived medicines including the International Library of Cannabinoids (ILC)
CannaHub was recently granted a EU REDI grant funding three doctoral students for three years, on areas of research,
guided by MGC, taking place at the partner institutions
International Library Of Cannabinoids
CannaHub
• ILC is the World’s first library of cannabis medicine where
provides an
details of medical cannabis clinical research, cannabinoid
interface
sequences and their treatments can be found
connecting
doctors and • ILC will collect data from diverse clinical studies, academic
patients with publications, patient feedback as well as diverse
clinical research CannaHub cannabinoid strains
and information • Collected and analysed data from the ILC will assist and
on cannabinoid enhance the work of doctors and researchers and improve
sequences and industry efficacy estimates of cannabinoid treatment of
their potential various disorders
treatments • ILC could be utilised for the design and implementation of
clinical trials via its mobile and web-based applications
MGC Pharma | Company Presentation | April 2021 16Manufacturing,
Distribution and
Patient Access
MGC Pharma | Company Presentation | April 2021 17EU-GMP Manufacturing Facilities
SLOVENIA: EU-GMP certified facility capacity to
manufacture up to 12,000 prescription products per
month – 3 year GMP license granted. Focus on
Investigational Medical Products
MALTA: CimetrATM manufacturing facility
~5 million AUD grant EU Grant, operational October
2021
Combined Ability to manufacture 200,000 units per
month under GMP conditions within the EU
MGC Pharma | Company Presentation | April 2021 18Key Global Distribution Partners
Extensive network in place providing access to hospitals, pharmacies and research institutions around the world
Lenis is the Company’s wholesaler/exporter to all distributors globally and is also a direct distributor to key European markets. The
Acquisition of Medicinal Cannabis Clinics also provides distribution and direct patient access across Australia
Europe
Asia
Africa
South Australia
America
MGC Pharma | Company Presentation | April 2021 19Key Patient Access Agenda
Strategic synergies providing expedited commercial growth
Relationships on the ground
Strategic Alliance with Australia’s leading Epilepsy Association, Epilepsy Action Australia
Creates Doctor & Market awareness
Leading to prescriptions via Early Patient Access Schemes
Giving MGC the ability to both wholesale and distribute directly to other clinics, pharmacies & patients to
reduce storage and distribution costs, while keeping prices consumer focused.
Taking ownership of the supply chain all the way to patient. MGC Pharma completed the
acquisition of 100% of the operating telehealth clinic - business assets, data and IP of
Medicinal Cannabis Clinics in November 2020, providing an additional operating platform
with import and distribution capacity
MGC Pharma | Company Presentation | April 2021 20Medicinal Cannabis Clinics (MCC) – the Next Phase of Growth in Australia
MGC Pharma has acquired 100% of MCC’s operating telehealth clinic − business assets, data and IP
About MCC Strategic rationale
Established in 2019 - a leading Australian telehealth Provides an established
medicinal cannabis clinic with an extensive doctor, operating platform
pharmacy and patient network with over 600
pharmacy and doctor
accounts.
4,500+ medical cannabis consultations Optimises control of
the supply chain from
manufacturing through
to patients thereby
Highly experienced medical team specialising in improving profit
cannabinoid medications margins while also
providing high-quality
GMP certified
Allows medication to be dispensed and delivered medications at
straight to the patient’s door affordable prices.
MGC Pharma | Company Presentation | April 2021 21Investment Proposition
Fully Integrated Model: Research ➜ Product Development ➜ Commercialise
Built on Decades of Experience Focussed Operations Strategically Located
Technical team of globally recognised Core divisions: Operational bases close to key
scientists and doctors • Research and Development markets supported by corporate
headquarters
• Manufacturing and Distribution
Robust Product Offering International Reach Strong Market Outlook
Portfolio of established and upcoming Strong network of research and Global phytocannabinoid market
products targeting key markets commercial partners globally gaining traction
MGC Pharma | Company Presentation | April 2021 22Disclaimer
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MGC Pharma | Company Presentation | April 2021 24https://mgcpharma.com.au/
@mgcpharamaceuticals
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MGC Pharmaceuticals Ltd
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